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Process Engineer II

Process Engineer II

Requisition Number 
17-984
Category 
Facilities
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

 

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

The Process Engineer II will provide engineering support for technology transfer, process validation, and GMP manufacturing for MacroGenics’ products. He/she will engage in automation and technology application activities within MacroGenics and with outside partners (i.e. vendors). He/she will work with the Manufacturing team to design and scale-out manufacturing processes, and support manufacturing operations, as well as improve existing manufacturing operations. This role will serve as a lead in the selection and implementation of new processing equipment and modifications to existing equipment in the GMP Manufacturing Facility and related systems. This individual will work closely with a cross functional team in order to meet the needs of the manufacturing facility.

 

Responsibilities and Job Duties

  • Lead the design, implementation, and commissioning for new processing equipment and modifications to existing equipment within GMP Manufacturing while maintaining company quality and safety standards.
  • Draft and review protocols, production procedures, and provide technical assessment and approval for engineering and process changes as well as documentation pertaining to process development, qualification, and validation to meet regulatory requirements.  
  • Work with industry experts/consultants to create design specifications, P&ID drawings, GA drawings, User Requirements, Functional Specifications and automation control strategies.  Drive standardization within the department and within the company.
  • Write and review technical documentation such as protocols and reports for FATs, SATs, and IQ/OQ/PQ testing.
  • Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating and troubleshooting equipment and process issues. Bring unresolved issues to supervisor and/or other team members.
  • Participate in cross-functional teams to improve existing processes and drive change to increase efficiencies or minimize waste.  Implement change management tactics to increase overall effectiveness of new processes and procedures.
  • Provide technical solutions to equipment and/or process problems, develop reports that evaluate multiple solutions, share findings with appropriate personnel and make recommendations for problem resolution.
  • Perform investigations of manufacturing deviations and anomalies related to failure of facility systems.
  • Perform process monitoring, process capability, statistical analysis and quality engineering activities.
  • Prepare new and revise current drawings on vendor-provided documents and in-house redlines.  Review drawings and designs for adherence to established specifications and standards.
  • Provide support with implementing new processes to the manufacturing area, assist with equipment process fit, lead any required equipment modifications, lead procurement activities for any needed new equipment. Support technology transfer.
  • Provide afterhours technical and troubleshooting support as needed.
  • Other duties as assigned.

Qualifications

Education & Credentials

Bachelor’s degree in Chemical, Biochemical or Mechanical Engineering, Biotechnology or a related degree or equivalent years of education and experience

 

Experience

  • Minimum of 2 years of related experience
  • Previous experience in manufacturing, development or supporting manufacturing operations, preferably in the biotech or pharmaceutical industry

Knowledge, Skills and Abilities

  • Working knowledge of cGMP manufacturing and regulatory requirements for biologics and pharmaceuticals
  • Ability to write technical reports and to develop data gathering schedules
  • Capable of performing risk assessments
  • Willingness to work with a “hands-on" approach in project construction, testing, and support
  • Must have effective oral and written communication skills
  • Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision.
  • Computer skills:  MS Office Suite, MS Project, and AutoCAD.

Preferred Qualifications

  • Capable of effectively negotiating contracts, bids, and change orders with vendors or contractors for equipment or systems
  • Demonstrates a proficient understanding of equipment, instrumentation, and materials of construction to design, specify, procure, start-up, fully commission and troubleshoot equipment and systems
  • Strong knowledge of industry standards and guidelines, such as ASME BPE, ISPE Baseline Guides and CFR’s
  • Equipment qualification experience in a cGMP environment (IQ, OQ, PQ)
  • Experience performing process design and process automation
  • Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar
  • Process validation experience
  • Experience performing discrete event simulation
  • Experience in statistical analysis using JMP or Minitab

Supervisory Responsibilities

None

 

 

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.